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Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer

P

Peking University

Status

Enrolling

Conditions

Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT05483452
ChiECRCT20220009

Details and patient eligibility

About

In recent years, template guidance has been applied and developed in the field of puncture related operations, such as template-assisted radioactive seed implantation. With the guidance of template, needle pathway of seed implantation, biopsy and fiducial marker implantation can be precisely planned actual operation, which is conducive to the accurate proceeding. Templates can be divided into coplanar templates and non-coplanar templates. The digital coplanar template coordinate puncture system has been developed in China and has been applied in clinical practice.

In previous studies, coplanar template assisted CT-guided radioactive seed implantation has good clinical feasibility for head and neck cancer. However, the accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic cancer are lacking in prospective studies. The study aims to prospectively observe the accuracy and safety of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic cancer.

Enrollment

34 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Ages 18 to 85
  2. Single or multiple abdominal or pelvic tumors (solid, partially solid)
  3. Without taking drugs affecting coagulation and/or platelet aggregation are used; If used, the drug has been discontinued for a sufficient period of time (e.g. 1 week)
  4. KPS>60 points with expected survival >3 months, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
  5. Planned seed implantation with applicable puncture path
  6. With informed consent.

Exclusion criteria

  1. Poor organ function (e.g. Liver decompensation)
  2. The lesion close to blood vessels and intestine, or there is portal vein hypertension and superior vena cava compression, etc., which are expected to have high risks of puncture bleeding and intestinal injury
  3. Poor compliance, unable to complete coordination
  4. Paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.

Trial contacts and locations

1

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Central trial contact

Bin Qiu, M.D.

Data sourced from clinicaltrials.gov

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